First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors

ClinicalTrials.gov ID: NCT01014936

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Official title

A Phase I Open-label, Non-randomized, Dose-escalation First-in-man Trial to Investigate the c-Met Kinase Inhibitor MSC2156119J Under Three Different Regimens in Subjects With Advanced Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: * Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) * Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) * Regimen 3: MSC2156119J every day for three weeks (21-day cycle)

Study identification

NCT ID: NCT01014936
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: EMD Serono; Industry
Enrollment: 149 participants

Conditions and interventions

Conditions

Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available

Interventions

MSC2156119J Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 30, 2009 (Actual)
Primary completion: Oct 31, 2015 (Actual)
Completion: Oct 31, 2015 (Actual)
Last update posted: Aug 24, 2022

2009 – 2015

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
M.D. Anderson Cancer Center	Houston	Texas	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01014936, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 24, 2022 · Synced Nov 14, 2026